Job Description
At CRISPR Therapeutics, we are focused on developing transformative gene-based medicines for serious human diseases.
We are rapidly translating our specific, efficient, and versatile CRISPR/Cas9 gene-editing platform into therapies to treat hemoglobinopathies, cancer, diabetes, and other diseases.
Our multi-disciplinary team of world-class researchers and drug developers works every day to translate our CRISPR/Cas9 technology into breakthrough human therapeutics. Our lead program targeting the blood diseases β-thalassemia and sickle cell disease has entered clinical testing, and our immuno-oncology programs, focused on CRISPR/Cas9-edited allogeneic CAR-T cell therapies, have the potential to deliver a new generation of cancer therapies to patients.
About the position:
- Oversee the development, optimization, and qualification/validation of robust molecular assays:
- NGS, qPCR, ddPCR and other molecular assay platforms for the characterization of cell and gene therapy drug products, vector, and critical starting material
- Evaluation of nucleic acid characteristics like residual impurity DNA, residual AAV and sgRNA
- Gene editing features like on- and off-target editing, etc.
- sgRNA sequencing
- Provide expertise for enhancing existing assays, and implementation of new ideas and technologies
- Provide leadership and guidance in designing and execution of method qualifications per ICH and regulatory guidelines.
- Represent the analytical development team in cross-functional CMC meetings, and actively participate in strategy design, execution, data presentation and follow-up.
- Form active collaboration with other teams within Analytical Development, Process development, Research and Quality teams.
- Collaborate with external partners, CMOs to lead or monitor outsourcing activities, manage timelines, and ensure deliverables.
- Author technical reports, protocols, and analytical sections of regulatory filings for US, Europe, and ROW.
Qualification Required:
- MS/Ph.D. in molecular biology, or related sciences such as cell biology, genetics, or immunology
- Minimum 8 years (Ph.D.) or 15 years (MS) of biopharma industry experience with demonstrated track record of successfully developing different molecular biology analytical methods using techniques like next-generation sequencing (NGS) platforms, Sanger sequencing, qPCR, droplet digital PCR (ddPCR)
- Next-generation sequencing (NGS) experience and proficiency with various molecular biology and sequence analysis software is required
- Experiences with bioinformatics programming is a plus
- Strong knowledge of CRISPR gene editing, and analytical methods for cell and gene therapy products is required
- Extensive knowledge and strong scientific background related to the products and underlying biology, applicability of the emerging or existing molecular assay platforms
- Prior hands-on experience with qualifying and validating assays; understanding of ICH/ FDA guidelines, and phase appropriate GMP requirements is required.
- Prior experience of IND, BLA or equivalent regulatory filings is highly preferred.
- Experiences with analytical or statistical software (e.g., JMP, Softmax Pro, Gen5 etc.), is highly desirable.
- Experience of working with and managing external vendors/ CROs is preferred.
- Experience working with LIMS is preferred
- Experience working with automation of analytics is preferred
- Strong writing, reviewing, and presentation skills is required.
- Must have strong organization skills, and experience of mentoring Ph.D.-level scientists is required.
- Ability to multi-task in a fast-paced environment with changing priorities.
- Highly motivated, detail oriented with good problem-solving ability.
Competencies
- Collaborative – Openness, One Team
- Undaunted – Fearless, Can-do attitude
- Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
- Entrepreneurial Spirit – Proactive. Ownership mindset.
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
